HPV VaccinationNCT07164391
Empowering Vietnamese Americans
A study testing Digital Intervention for Vietnamese-American Storytelling (VIDAS) and Teen General Health in people with HPV Vaccination and Cancer Prevention, run by Michigan State University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether short videos can help Vietnamese American mothers decide to vaccinate their children against HPV (human papillomavirus). The study will explore: (1) whether different interventions influence mothers' intentions and decisions regarding HPV vaccination for their… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HPV Vaccination, Cancer Prevention
- What is being tested?
- Digital Intervention for Vietnamese-American Storytelling (VIDAS) and Teen General Health
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identify as a Vietnamese American or immigrant woman aged 18 years or older
- Are the primary caregiver of at least one unvaccinated child aged 11-14 years
- Can speak and read English or Vietnamese
- Agree to receive text messages and/or emails related to project activities during the study period
Who cannot join
- inability/unwillingness to provide consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Michigan State University
Lansing, Michigan, 48824
Megan Whaley, MS, 517-884-4622, whaleym1@msu.edu
About this study
Official title: Empowering Vietnamese Americans: A Culture-Centric Digital Storytelling Intervention to Boost HPV Vaccination
The goal of this clinical trial is to learn whether short videos can help Vietnamese American mothers decide to vaccinate their children against HPV (human papillomavirus). The study will explore: (1) whether different interventions influence mothers' intentions and decisions regarding HPV vaccination for their children; (2) how mothers perceive and engage with the videos; and (3) how many children receive the HPV vaccine after their mothers watch the videos.
Participants will be randomly assigned to one of two groups: (a) watch four short digital stories about the HPV vaccine created by Vietnamese mothers; or (b) watch four short videos on general teen health topics such as mental health and social media use. Participants will complete brief surveys and their child's HPV vaccination status will be checked two months after the intervention.
Read the detailed description
This study focuses on increasing HPV vaccination rates among Vietnamese American (VA) youth by engaging their mothers-who are key decision-makers-in culturally relevant video interventions. VA females experience disproportionately high rates of HPV-related cervical cancer and low vaccine uptake. Contributing factors include limited HPV knowledge, low English proficiency, and culturally influenced health beliefs. There is a critical need for tailored, community-driven interventions to address these disparities.
Researchers will evaluate two 4-week video-based interventions: a digital storytelling (DST) intervention featuring personal stories created by Vietnamese mothers and a general teen health video series. Each mother will view one 3-minute video per week over four weeks. The study uses a randomized, 2-arm design with 60 VA mothers of unvaccinated children ages 11-14 assigned to one of the two groups.
The study draws on the Theory of Planned Behavior and a culture-centric health promotion framework. It aims to measure feasibility, acceptability, and changes in vaccination intention and behavior. Follow-up assessments will occur two months post-intervention to evaluate vaccine uptake. Additionally, a subset of participants will complete interviews to explore engagement and refine future trial design.
Data will be collected at baseline, post-intervention, and 2-month follow-up using online surveys and secure platforms. To ensure equitable participation, the study incorporates bilingual staff, culturally tailored outreach and community partnerships. Findings will inform future large-scale trials and may help scale culturally grounded HPV prevention strategies for other underserved populations.
- Conditions
- HPV Vaccination, Cancer Prevention
- Being tested
- Digital Intervention for Vietnamese-American Storytelling (VIDAS), Teen General Health
- Keywords
- HPV, cancer prevention, Vietnamese American, youth, digital storytelling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Intervention for Vietnamese-American Storytelling (VIDAS)Behavioural
The intervention consists of 4 brief stories about HPV vaccine, created by Vietnamese mothers
Teen General HealthBehavioural
This intervention consists of 4 brief videos on general teen health topics, such as mental health, social media usage.
| Study group | Role | What they receive |
|---|---|---|
| Story group | Active comparator | This group will receive the digital Intervention for Vietnamese-American Storytelling (VIDAS) Receives: Behavioral: Digital Intervention for Vietnamese-American Storytelling (VIDAS) |
| Teen General Health group | Placebo comparator | This group will receive the Teen General Health intervention. Receives: Behavioral: Teen General Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child's HPV vaccine initiation
Whether the target child receives the 1st HPV vaccine
Measured: 2-month follow up (T2)
Mother's intention to vaccinate the eligible child against HPV
One item to measure mother's intention to vaccinate the eligible child against HPV
Measured: T0 (baseline), T1 (immediately post intervention), T2 (2-month follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Oct 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV VaccinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Chia-Chen Chen, Michigan State University
- Investigators
- ANGELA CHIA-CHEN CHEN, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164391
- Sponsor's protocol ID
- IP00769244
- Status last verified
- May 2026
- First submitted
- 9 Jun 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Privacy and ethical issues
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Vietnamese Americans: A Culture-Centric Digital Storytelling Intervention to Boost HPV Vaccination
- ClinicalTrials.gov ID
- NCT07164391
- Acronym / sponsor ID
- IP00769244
- Conditions
- HPV Vaccination, Cancer Prevention
- Keywords
- HPV, cancer prevention, Vietnamese American, youth, digital storytelling
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether short videos can help Vietnamese American mothers decide to vaccinate their children against HPV (human papillomavirus). The study will explore: (1) whether different interventions influence mothers' intentions and decisions regarding HPV vaccination for their children; (2) how mothers perceive and engage with the videos; and (3) how many children receive the HPV vaccine after their mothers watch the videos.
Participants will be randomly assigned to one of two groups: (a) watch four short digital stories about the HPV vaccine created by Vietnamese mothers; or (b) watch four short videos on general teen health topics such as mental health and social media use. Participants will complete brief surveys and their child's HPV vaccination status will be checked two months after the intervention.
Detailed description
This study focuses on increasing HPV vaccination rates among Vietnamese American (VA) youth by engaging their mothers-who are key decision-makers-in culturally relevant video interventions. VA females experience disproportionately high rates of HPV-related cervical cancer and low vaccine uptake. Contributing factors include limited HPV knowledge, low English proficiency, and culturally influenced health beliefs. There is a critical need for tailored, community-driven interventions to address these disparities.
Researchers will evaluate two 4-week video-based interventions: a digital storytelling (DST) intervention featuring personal stories created by Vietnamese mothers and a general teen health video series. Each mother will view one 3-minute video per week over four weeks. The study uses a randomized, 2-arm design with 60 VA mothers of unvaccinated children ages 11-14 assigned to one of the two groups.
The study draws on the Theory of Planned Behavior and a culture-centric health promotion framework. It aims to measure feasibility, acceptability, and changes in vaccination intention and behavior. Follow-up assessments will occur two months post-intervention to evaluate vaccine uptake. Additionally, a subset of participants will complete interviews to explore engagement and refine future trial design.
Data will be collected at baseline, post-intervention, and 2-month follow-up using online surveys and secure platforms. To ensure equitable participation, the study incorporates bilingual staff, culturally tailored outreach and community partnerships. Findings will inform future large-scale trials and may help scale culturally grounded HPV prevention strategies for other underserved populations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Story group | Active comparator | Behavioral: Digital Intervention for Vietnamese-American Storytelling (VIDAS)This group will receive the digital Intervention for Vietnamese-American Storytelling (VIDAS) |
| Teen General Health group | Placebo comparator | Behavioral: Teen General HealthThis group will receive the Teen General Health intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-identify as a Vietnamese American or immigrant woman aged 18 years or older
- Are the primary caregiver of at least one unvaccinated child aged 11-14 years
- Can speak and read English or Vietnamese
- Agree to receive text messages and/or emails related to project activities during the study period
Key exclusion criteria (1 listed)
- inability/unwillingness to provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Intervention for Vietnamese-American Storytelling (VIDAS)The intervention consists of 4 brief stories about HPV vaccine, created by Vietnamese mothers | Behavioural | Story group |
| Teen General HealthThis intervention consists of 4 brief videos on general teen health topics, such as mental health, social media usage. | Behavioural | Teen General Health group |
Primary outcome
Child's HPV vaccine initiation
Time frame: 2-month follow up (T2)
Whether the target child receives the 1st HPV vaccine
Mother's intention to vaccinate the eligible child against HPV
Time frame: T0 (baseline), T1 (immediately post intervention), T2 (2-month follow up)
One item to measure mother's intention to vaccinate the eligible child against HPV
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Undecided. Privacy and ethical issues
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ANGELA CHIA-CHEN CHEN, PhD principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Intervention for Vietnamese-American Storytelling (VIDAS) and Teen General Health in people with HPV Vaccination and Cancer Prevention, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Whaley, MS (517-884-4622, whaleym1@msu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child's HPV vaccine initiation (time frame: 2-month follow up (T2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.